Background Scopo del progetto di ricerca è valutare se l'utilizzo della core decompression associata a medicina rigenerativa (gel piastrinico, concentrato midollare autologo e matrice ossea demineralizzata) è sicuro ed efficace nel trattamento dell'osteonecrosi della testa del femore, anche per gli stadi più avanzati Materiali e metodi Inclusi in due protocolli di ricerca (ON-08 e AVN-13) sono stati trattati più di 50 pazienti, dei quali 29 con adeguato follow up (29 anche trattate). Nella stessa procedura il midollo osseo viene aspirato e concentrato, poi si procede alla core decompression ed il materiale rigenerativo (demineralizzato, concentrato midollare e gel piastrinico) vengono introdotti all'interno della lesione con approccio mini invasivo. I pazienti vengono poi valutati clinicamente e con radiografie standard e risonanza magentica nucleare ogni 3 mesi. L'outcome primario è stato valutare la sopravvivenza al trattamento (intesa come non conversione in artroprotesi) mentre gli obiettivi secondari sono stati la valutazione dei sintomi (dolore), della clinica (funzione) e la valutazione degli esami strumentali. Results La progressione radiografica è stata riscontrata in 7 anche. Complicazioni in 2 pazienti (una frattura ed una infezione). 16 anche hanno invece riportato risultati buoni o eccellenti con HHS > 80 a 2 anni di follow up. La protesi è stata indicata in 8 casi (27%). Nei casi falliti, lo stadio di nerosi era IIB in 6 e IIA in uno, mentre stadio III in 2 pazienti. Conclusioni I risultati preliminari sono promettenti in quanto sovrapponibili a quelli disponibili in letteratura. In particolare ottimi risultati clinico-funzionali nei pazienti giovani, affetti da neoplasie ematologiche. Ad ogni modo, è necessario un follow up maggiore ed una corte più ampia di pazienti per confermare i buoni risultati ottenuti. / Background We aim to assess whether the use of core decompression and the application of autologous bone marrow concentrate (BMC) along with demineralized bone matrix (DBM) and Platelet Rich Fibrin (PRF) in the treatment of osteonecrosis of the femoral head (ONFH) is safe and effective and whether this technique is indicated in advanced stages. Methods Twenty-nine patients (30 hips) were enrolled in this clinical trial at the Rizzoli Orthopaedic Institute. In the same procedure bone marrow was aspirated and concentrated, then core decompression was performed and BMC mixed with DBM and PRF was introduced into the lesion. Patients were assessed postoperatively with X-Ray and MRI. Primary outcome was the survival rate of hips not converted to total hip arthroplasty (THA). The secondary outcomes were radiographic evolution and clinical symptoms evaluated with Harris Hip Score (HHS). Results Radiographic progression was found in 7 hips. There were complications in 2 hips (one fracture and one deep infection). Sixteen hips with successful treatment had good to excellent functional results at 2-year follow-up (HHS > 80). THA were indicated in 8 hips (27%). In failed cases, the Ficat stage was IIB in 6 and 1 IIA and III respectively in the other two patients. Conclusions The early outcomes of our procedure are similar compared to the literature with promising results in post collapse stages, particularly in young patients treated for haematological malignancies. However, a longer follow-up and more selective study criteria are needed to confirm the present data

Congenital heart defects (CHD) have an incidence of 4-8/1000 live births and encompass a broad spectrum of disorders. Due to advances in cardiac surgery and cardiology care, most children born with CHD are now surviving into adulthood and there are currently more adults affected than children. Exercise capacity is reduced across the spectrum of patients with CHD, both in natural history and after surgical and interventional treatment. The aim of this project was to better understand exercise limitations and safety/usefulness of training in young patients with heart disease across a broad spectrum of disorders and in particular we focused on left-to-right shunts, systemic right ventricular physiology, univentricular physiology with Fontan palliation and dilated cardiomyopathy. Future perspective include exploring new ways of engaging teenagers with univentricular palliation in systemic and respiratory muscle training. Furthermore, the collaboration with biomedical engineers will allow us to gain in depth understanding of univentricular physiology. Similarities exisit in the physiological changes observed during exercise and pregnancy and the final goal is to implement the model with these variables to achieve better clinical outcome in this growing population of young adults with complex lesions and limited exercise and child-bearing potential. Exercise testing and training are becoming more and more relevant to guide therapy and management but also to assess the ability in daily activities that play an important role in many aspects of life that have not been addressed specifically until now. The increasing data available enable physicians to give adequate counseling regarding vocational or professional choices, suitable leisure activities and family planning according to the levels of activity considered safe and sustainable in the specific physiology. Further studies will warrant deeper understanding of issues that are specific to univentricular physiology and will help us to target interventions to improve quantity and quality of life.

Autologous bone grafting is a standard procedure for the clinical repair of skeletal defects, and good results have been obtained. Autologous vascularized bone grafting and allografts are often used, presenting several drawbacks. On the other side, several studies in literature reported the ability of bone marrow derived cells to promote neo-vascularization thanks to specific GF, hematopoietic and nesenchymal stem cells. In this scenario a new procedure was developed, consisting in an allogenic bone graft transplantation in a critical size defect in rabbit radius, plus a deviation at its inside of the median artery and vein with a supplement of autologous bone marrow concentrate on a collagen scaffold. Twenty-four rabbits were were operated with different experimental and control procedures. For each group, 3 experimental times: 8, 4 and 2 weeks. An in vitro evaluation of bone marrow concentrate was performed and at the time of sacrifice histological and histomorphometrical assessment were performed with immunohistochemical assays for VEGF, CD31 e CD146 to highlight the presence of vessels and endothelial cells. Micro-CT Analysis with quantitative bone evaluation was performed. The bone marrow concentrate showed a marked capability to differentiate into osteogenic, chondrogenic and agipogenic lineages. No complications were reported. The bone grafts showed only a partial integration, mainly at the extremities in the group with vascular and bone marrow concentrate supplement. Immunohistochemistry showed an interesting higher VEGF expression in the same group. Micro CT analysis showed a higher remodeling activities in the groups treated with vascular supplement, with an area of integration at the extremities increasing with the extension of the sacrifice time. The present study suggests that the vascular and marrow cells supplement may positively influence the neoangiogenesis and the neovascularization of the homologous bone graft.

No-reflow occurring during PCI has been associated with poor outcomes. The objectives of this study were to evaluate the incidence of no-reflow as independent predictor of adverse events and to assess whether baseline pre-procedural treatment options may affect clinical outcomes. Data were derived from the ISACS-TC (NCT01218776) registry, a prospective survey of patients presenting with ACS over a 5-year period. Data were prospectively collected from 5997 patients undergoing PCI, identifying those with no-reflow, and analyzed their treatments and outcomes. No-reflow was defined as post-PCI TIMI flow grade 0-1, in the absence of post-procedural significant (≥25%) residual stenosis, abrupt vessel closure, dissection, perforation, thrombus of the original target lesion, or epicardial spasm. The outcome measure was in-hospital mortality. No-reflow was identified in 128 (2.1%) patients. On multivariate analysis, patients with no-reflow were more likely to be older (OR:1.20, 95%CI:1.01–1.44) and to be admitted with a diagnosis of ST-elevation myocardial infarction (OR:2.96, 95%CI:1.85–4.72). No-reflow was highly predictive of in-hospital mortality (17.2% vs. 4.2%, P<0.001) and remained a significant independent predictor of death after adjustment for demographic and clinical variables (OR:4.60,95%CI:2.61–8.09). Multivariable regression analysis was also performed to identify independent relationship between pre-procedural treatment regimens, angiographic characteristics and no-reflow phenomenon. Administration of pre-procedural unfractioned heparin, showed a strong inverse predictive value in terms of post-PCI TIMI flow and no-reflow phenomenon (OR: 0.65, 95%CI:0.43–0.99). Similarly, a 600-mg loading dose of clopidogrel showed a trend associated with a reduction in the likehood of no-reflow (OR:0.61,95%CI:0.37–1.00). Angiographic characteristics associated with no-reflow phenomenon were stenosis≥50% of the right coronary artery, presence of multivessel coronary disease and pre-procedural TIMI blood flow grade 0-1. In conclusion, no-reflow during PCI is a strong independent predictor of mortality. Pre-procedural administration of 600-mg loading dose of clopidogrel and/or unfractioned heparin is associated with reduced incidence of no-reflow.

The aim of our RCT was to evaluate safety and efficacy of a new device called Prevention Nail System (PNS) developed for the prevention of femoral neck fractures (FNFs) in patients with severe osteoporosis. The PNS is a titanium screw with a hydroxyapatite coating implanted in the femoral neck in order to reinforce it. We enrolled patients with: FNF; age ≥65 years; DXA of the noninjured hip with a T-score ≤ −2.5 SD. In the fractured hip patients received standard treatment while the contralateral hip was randomized either to receive PNS (group A) or not: control group (B). During each follow-up (FU) at 3, 12 and 24 months, DXA, CT and X-rays of the reinforced hip were performed. The mean age was 83 years and the preoperative DXA was −3.3 SD in both groups. The walking ability of patients with PNS were comparable to controls. The CT scan showed good integration of the PNS in the bone. At the longest available FU 23 patients reported one or more falls. 16 nonfemoral fractures were recorded: 10 (A) and 6 (B) and 6 contralateral hip fractures (CHFs): 3 in the PNS group and 3 in the control group. In A all CHFs occurred within 1 month after surgery and there was a difficult screw placement during surgery, in the control group the CHFs were consequence of a fall (6 months to 2 years after the first FNF). No statistical differences were reported between groups A and B. In conclusion, the device was well tolerated; CHFs in the PNS group should be considered a technical error due to the surgical instruments. Safety of the device can be increased by improving the instruments to reduce the risk of iatrogenic fractures.

Introduzione: Scopo dello studio è stato analizzare i risultati oncologici e funzionali di un’ampia casistica multicentrica di pazienti trattati chirurgicamente per condorsarcoma (CS) della pelvi. Materiali e metodi: La casistica comprende 309 pazienti trattati nel periodo 1975-2013: 193 uomini (63%) e 116 donne (37%) con un età media di 46,4 anni (15-81 anni). I CS erano centrali in 136 casi (34 grado 1; 83 grado 2; 19 grado 3), periferici in 109 (60 grado 1; 47 grado 2; 2 grado 3), dedifferenziati in 36, a cellule chiare in 4, mesenchimali in 2 e periostei in 3, mentre in 19 casi non era nota la variante istologica. Il tumore aveva una localizzazione di tipo I in 74 casi, I-IV in 13, I-II in 39, II-III in 57, III in 35, II in 42 e I-II-III in 49 casi. Un’amputazione interileoaddominale è stata effettuata in 49 pazienti (16%), mentre 260 (84%) sono stati trattati conservativamente: 144 resezioni senza ricostruzione e 116 resezioni con ricostruzione. Margini ampi in 212 casi, ampi contaminati in 23, marginali in 50 ed intralesionali in 24 casi. Risultati: La sopravvivenza a 10 e 15 anni è stata rispettivamente del 73% e 70%. Ad un follow-up medio di 9 anni (range 2-32 anni), 188 pazienti (61%) risultavano continuativamente liberi da malattia, 28 liberi dopo trattamento di recidiva locale (9%), 54 (17%) deceduti per malattia, 13 (4%) deceduti per altre cause e 26 (8%) vivi con malattia. L’alto grado istologico ed il sottotipo dedifferenziato correlano significativamente con peggior prognosi (p<0,0001). All’analisi multivariata sulla sopravvivenza, stadio e grado influenzano significativamente la prognosi. L’incidenza di recidiva locale è stata del 27,8% (86 pazienti). Conclusioni: La chirurgia conservativa è il trattamento “gold standard”. La localizzazione acetabolare pone importanti difficoltà tecniche per la ricostruzione. C’è una correlazione significativa tra grado tumorale e sopravvivenza. / Introduction. Aim of this study was to review the long-term oncologic and functional outcome of surgical management in a large series of patients with pelvic chondrosarcoma (CS). Material and Methods. We analyzed 309 patients treated between 1975-2013: 193 males (63%) and 116 females (37%) with a mean age of 46.4 years (range, 15-81 years). There were 136 central CSs (34, 83 and 19 cases grade 1, 2 and 3 respectively), 109 peripheral CSs (60, 47 and 2 cases grade 1, 2 and 3), 36 dedifferentiated CSs, 4 clear cell CSs, 2 mesenchymal CSs and 3 periosteal CSs, 19 otherwise defined CSs. Tumor site was classified as type I in 74 cases, I-IV in 13, I-II in 39, II-III in 57, III in 35, II in 42 and I-II-III in 49 cases. Forty-nine patients had an external hemipelvectomy (16%), whereas 260 patients (84%) underwent a limb-salvage procedure: 144 resections without reconstruction and 116 resections with reconstruction. Margins were wide in 212 cases, wide but contaminated in 23, marginal in 50 and intralesional in 24 cases. Results. Survival on Kaplan Meier curve was 73% and 70% at 10 and 15 years respectively. At a mean of 9 years (1 to 32 years), 188 patients (61%) were continuously NED, 28 were NED after treatment of local recurrence (9%), 54 (17%) DWD, 13 (4%) died of other causes and 26 (8%) AWD. In central and peripheral CSs, high-grade tumors correlated with worse survival. Dedifferentiated CS had a significantly worst prognosis (p<0.0001). At multivariate analysis on survival, stage and grade statistically influenced prognosis. Overall incidence of local recurrence was 27.8% (86 patients). Conclusions. Surgery is the mainstay of treatment for pelvic CS. CSs with acetabular involvement offer challenging technical problems to reliable and lasting reconstruction. There was a significant correlation between histologic grade and survival.

Background: i dati relativi agli indicatori prognostici nei pazienti con ipertensione arteriosa polmonare (IAP) derivano da coorti storiche di pazienti in terapia medica convenzionale o da piccoli gruppi di pazienti in terapia con un singolo farmaco. Oggi abbiamo tre diverse classi di farmaci che hanno dimostrato di migliorare la prognosi dei pazienti con IAP. Obiettivo: analisi dei fattori prognostici e risposta al trattamento nei pazienti con IAP. Materiali e Metodi: Da gennaio 1999 al 31 luglio 2015, abbiamo analizzato 1040 pazienti con IAP [età media 50 ± 18 anni] 370 (36%) con IAP idiopatica non-responder al test di vasoreattività acuta (IAPI-Nresp); 78 (8%) con IAPI responder al test acuto di vasoreattività polmonare (IAPI-resp); 215 (21%), con IAP associata a malattie del tessuto connettivo (PAH-MTC); 203 (19%) con IAP associata a shunt cardiaci congeniti (PAH-CC); 115 (10%) con IAP associata a ipertensione portale (IAP-Po); 59 (6%), con IAP associata ad infezione da HIV (IAP-HIV). La valutazione basale includeva esame obiettivo, classe funzionale WHO, test dei 6 minuti di marcia (6MWD) e cateterismo cardiaco destro. Risultati: 80% pazienti con IAP-Nresp,76% dei pazienti IAP-CC, 90% dei pazienti con IAP-MTC, 81% dei pazienti IAP-Po,80% dei pazienti con IAP-HIV assumevano terapia specifica. La migliore sopravvivenza a 1, 3, 5 anni è stata per il gruppo IAP-CC (95%,87%,79%), la peggiore per il gruppo PAH-MTC (79%,58%,36%) All’ analisi multivariata il 6MWD è stato predittore di mortalità nel gruppo IAP-MTC, IAP-Nresp, IAP-CC; l'età e il sesso solo nel gruppo IAPI-Nresp, mentre la pressione atriale destra e l’indice cardiaco nei gruppi IAP-CC e IAP-MTC. Conclusioni: nonostante una strategia terapeutica standardizzata,la sopravvivenza dei pazienti con IAP rimane estremamente eterogenea. La migliore sopravvivenza resta quella dei pazienti IAPI-Resp e IAP-CC mentre la prognosi peggiore quella dei pazienti IAP-MTC. 6MWT è risultato il predittore indipendente di mortalità comune ai tre gruppi principali. / Background: Data about prognostic indicators in patients with pulmonary arterial hypertension (PAH) are derived from historical cohorts of patients in conventional medical therapy or by small groups of patients on therapy with a single drug. Today we have three different classes of drugs which have shown to improve the prognosis of PAH patients. Aim: to analyze the prognostic factors and treatment response in patients with PAH. Materials and Methods: From January 1999 to 31 July 2015, we analyzed 1040 PAH patients [mean age 50 ± 18 years] 370 patients (36%) with idiopathic PAH non-responder to acute vasoreactivity test (IPAH-Nresp); 78 (8%) with IPAH responder to acute testing of pulmonary vasoreactivity (IPAH-resp); 215 (21%) with PAH associated with connective tissue diseases (PAH-CTD); 203 (19%) with PAH associated with congenital cardiac shunts (PAH-CHD); 115 (10%) with PAH associated with portal hypertension (PAH-Po); 59 (6%) with PAH associated with HIV infection (HIV-PAH). Baseline evaluation included physical examination, WHO functional class, 6-minute walk test (6MWD) and right heart catheterization. Results: 80% PAH-Nresp patients, 76% PAH-CHD patients, 90% of PAH-CTD patients, 81% PAH-Po patients and 80% of PAH-HIV patients were taking specific therapy for PAH The best survival at 1, 3, 5 years was for PAH-CC (95%,80%73%),the worse prognosis was for PAH-CTD (79%, 58%, 36%) At the multivariate analysis 6MWD is predictor of mortality in PAH-Nresp, PAH-CHD and PAH-CTD patients. Age and sex were predictors of mortality only in IAPI-Nresp group while parameters indicative of right ventricular function are predictors in IAP-CHD and IAP-CTD group (right atrial pressure and cardiac index respectively) Conclusions: although standardized therapeutic strategy, survival of the PAH patients remains extremely heterogeneous. The better survival is for PAH-CHD and IPAH-Resp patients while the worst prognosis is for PAH-CTD patients. 6MWT is the best independent predictor of prognosis in the three main group.

Il rachide è stato suddiviso in tre colonne da Denis: anteriore e centrale comprendono la metà anteriore del corpo vertebrale, la metà posteriore e l’inizio dei peduncoli, mentre la colonna posteriore comprende l’arco e i peduncoli stessi. In caso di resezione o lesione della colonna anteriore e media è indicata la ricostruzione. Diverse tecniche e materiali possono essere usati per ricostruire il corpo vertebrale. Innesti vascolarizzati, autograft, allograft sono stati usati, così come impianti sintetici di titanio o materiale plastico come il PEEK (Poly etere etere ketone). Tutti questi materiali hanno vantaggi e svantaggi in termini di proprietà intrinseche, resistenza meccanica, modulo di elasticità, possibilità di trasmissione malattie, capacità di fondersi con l’osso ospite o meno. Le soluzioni più usate sono le cage in titanio o carbonio, il PMMA ( Poli methil metacrilato), gli innesti ossei massivi. Si è effettuato uno studio di coorte retrospettivo paragonando due gruppi di pazienti oncologici spinali trattati da due chirurghi esperti in un centro di riferimento, con vertebrectomia e ricostruzione della colonna anteriore: un gruppo con cage in carbonio o titanio, l’altro gruppo con allograft massivo armato di innesto autoplastico o mesh in titanio. Si sono confrontati i risultati in termini di cifosi segmenterai evolutiva, fusione ossea e qualità di vita del paziente. Il gruppo delle cage in carbonio / titanio ha avuto risultati leggermente migliori dal punto di vista biomeccanico ma non statisticamente significativo, mentre dal punto di vista della qualità di vita i risultati sono stati migliori nel gruppo allograft. Non ci sono stati fallimenti meccanici della colonna anteriore in entrambi i gruppi, con un Fu tra 12 e 60 mesi. Si sono paragonati anche i costi delle due tecniche. In conclusione l’allogar è una tecnica sicura ed efficace, con proprietà meccaniche solide, soprattutto se armato con autograft o mesi in titanio. / According to Denis the spine can be subdivided in 3 columns: anterior and central made by the anterior half and posterior half of the vertebral body, and posterior column made by the pedicles and posterior arch. Reconstruction of large anterior and middle column defects is indicated in a number of pathological entities including tumor, infection, trauma and post traumatic deformity, usually after a previous partial or total vertebral body resection. Several substitutes and techniques are available for the functional restoration of the vertebral column. Vascularized bone transfers, autografts, allografts or xenografts have been used, as well as metal, plastic or ceramic implants. All of these bear potential advantages and drawbacks in terms of associated morbidity of graft harvesting, disease transmission, mechanical failure, implant incorporation and over all long term outcome. The most frequently used solutions are: PMMA, Titanium Mesh Cages, Carbon Fiber Stackable cages, Massive allografts. a retrospective cohort study has been done comparing two groups of oncologic spine patients treated by 2 surgeons with vertebrectomy and anterior reconstruction: one group with cages, the other with allograft. We have compared results in terms of post surgical kyphosis and its worsening in time, fusion of the graft, quality of life. Results have been slightly better in the cage group but with no statistical relevance. No mechanical failure of the anterior column in both groups with a FU range from 12 to 60 months. A cost comparison has also been made. In conclusion we have realized allograft are a safe and cheap alternative to carbon fiber cages, with strong mechanical properties above all if helped by small titanium cages or rib autograft inside.

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